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Johnson & Johnson and Bayer plan to apply by year-end for U.S. and EU authorization to promote Xarelto, or rivaroxaban, as treatment for acute coronary syndrome. The filings will include Phase III trial data showing that Xarelto combined with standard anti-clotting therapy reduces the incidence of stroke, heart attack and cardiovascular death. Xarelto was approved for certain patients undergoing surgery and recommended for preventing stroke related to atrial fibrillation.

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Draft proposals were published by the U.K. National Institute for Health and Care Excellence recommending Bayer's Xarelto, or rivaroxaban, as an option for preventing blood clots in patients who have had a heart attack caused by cardiac blood vessel narrowing or blockage. The guidance does not cover patients with unstable angina, but only those with severe acute coronary syndrome resulting in cardiac biomarkers being released into the blood.

Bayer and Johnson & Johnson received FDA approval to promote Xarelto, an oral factor Xa inhibitor, for stroke prevention among patients with nonvalvular atrial fibrillation. The agency assigned a black-box warning that advises against discontinuation of therapy without medical advice. Xarelto, or rivaroxaban, was originally indicated as anti-clotting treatment after knee- or hip-replacement surgery.

Johnson & Johnson and Bayer plan to apply by year-end for U.S. and EU authorization to promote Xarelto, or rivaroxaban, as treatment for acute coronary syndrome. The filings will include Phase III trial data showing that Xarelto combined with standard anti-clotting therapy reduces the incidence of stroke, heart attack and cardiovascular death. Xarelto was approved for certain patients undergoing surgery and recommended for preventing stroke related to atrial fibrillation.

Bayer filed for European approval of anticoagulant Xarelto, or rivaroxaban, to prevent stroke in patients with atrial fibrillation. Meanwhile, partner Johnson & Johnson filed a marketing application with the FDA for the same indication. J&J also submitted additional data to the FDA concerning Xarelto's use after major orthopedic surgery.